Testing the Gravitostat in Humans: the Impact of a Weighted Vest in Patients Post Bariatric Surgery on Fat-free Mass Retention and Weight Loss

NCT04809129 | Suspended DMC

• 1 other identifier: RS20-012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The mechanisms regulating fat mass homeostasis are incompletely understood although recent animal and human trials would suggest that there is a leptin independent regulatory pathway which may play a role in weight control and maintenance. Although evidence would suggest that external loading in patients with obesity may promote body weight loss, this has not been explored in patients following bariatric surgery. The aim of this study is to investigate the mechanisms regulating weight loss and the potential role of the 'gravitostat' in fat free mass retention in patients following bariatric surgery.

Conditions

Obesity

Keywords

Bariatric surgery; Obesity; Weight loss maintenance

Outcome Measures

Primary Outcomes (2)

• Fat free mass retention

  Fat free mass retention as measured using DEXA scan

  1 year

• Weight loss

  Weight loss (kg)

  1 year

Secondary Outcomes (5)

• Changes in protein and inflammatory marker levels myostatin

  1 year

• Changes in protein and inflammatory markers lipocalin-2

  1 year

• Changes in protein and inflammatory markers IGF-1

  1 year

• Changes in protein and inflammatory markers IL-6

  1 year

• Changes in protein and inflammatory markers

  1 year

Study Arms (2)

External mechanical loading

EXPERIMENTAL

Following bariatric surgery (RYGB or SG) patients will be asked to wear a weighted vest for a minimum of 8 hours daily and during physical exercise for three months postoperatively. Weight will be incrementally added on a weekly basis to maintain the baseline weight as patients lose weight following surgery up to a maximum of 15%.

Device: Weighted vest

Standard postoperative care

NO INTERVENTION

Patients following bariatric surgery (RYGB or SG) will receive standard postoperative care.

Interventions

Weighted vest DEVICE

Patients will wear a weighted vest following bariatric surgery with weight increased incrementally to maintain baseline weight. This vest will be worn for a minimum of 8 hours a day for three months postoperatively.

External mechanical loading

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing bariatric surgery- Roux en Y gastric bypass or sleeve gastrectomy
• Age 18-60
• BMI \>30kg/m2
• Reporting regular physical exercise (\>3 days/week)
• Willingness to comply with the study protocol

You may not qualify if:

• Sedentary lifestyle
• Chronic pain that is constant and impairs the quality of life such as severe back, hip or knee pain
• Reduced mobility requiring the use of a mobility aid
• Undergoing revisional surgery
• Concerns from the investigator that the participant will be unable to fully comply with the study protocol

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

University College Dublin Clinical Research Centre

Dublin, Dublin 4, Ireland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carel W le Roux, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: April 8, 2021
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)